探讨四方双歧杆菌片和金桂仁气丸对糖尿病肾病患者肠道菌群及代谢的影响。该研究于2021年3月至2022年12月在长治医学院和平医院进行，共纳入30例糖尿病肾病患者。精心挑选糖尿病肾病患者作为研究对象。采用双盲随机表法，将这些患者随机分为三组：对照组（n = 10）、两歧双歧杆菌四方片组（n = 10）和金匮仁气丸组（n = 10）。 10）。对照组接受糖尿病肾病标准西医治疗，包括血糖、血脂、血压管理和其他常规治疗。除标准治疗外，两歧双歧杆菌片组给予双歧杆菌四方片治疗，金匮仁气丸组给予金匮仁气丸治疗。 4周治疗前后评估各种基线参数，包括空腹血糖、餐后2小时血糖、甘油三酯、血清总胆固醇、血清低密度脂蛋白胆固醇、血清高密度脂蛋白胆固醇、随机尿微量白蛋白/肌酐比值（ACR）、血肌酐（SCr）和中医证据评分。采集三组患者治疗前后的粪便标本进行16S rDNA高通量测序，并进行包括OUT聚类、Alpha多样性、Beta多样性、物种组成分析、LEfSe分析、KEGG功能预测等综合分析。采用Spearman相关分析探讨肠道菌群与临床指标的关系。另外,四点双歧杆菌片组和对照组患者在干预前后采集空腹外周静脉血,测定肿瘤坏死因子-α(TNF-α)、白细胞介素-2(IL-2)的光密度值。 ，和白细胞介素6（IL-6）使用北京Biolite ELISA试剂盒。本研究经长治医学院伦理委员会批准进行。 1．观察金匮仁气丸组、两歧双歧杆菌片组和对照组糖尿病肾病（DKD）患者的2hPBG、总胆固醇和LDL水平（p < 0.05）。 2.金匮仁气丸在缓解中医症状和降低ACR方面均优于两歧双歧杆菌片组和对照组。相反，与金匮仁气丸和对照组相比，四方双歧杆菌片的TC水平降低更为明显。值得注意的是，两歧双歧杆菌四方片可有效降低 DKD 患者的 (IL-2) 水平。 3. 双歧杆菌四方片也显示出降低 DKD 患者 IL-2 水平的功效。 4.干预前后以及三组间肠道微生物丰度和多样性分析均未发现明显变化。同样，ACE、Chao、Simpson 和 Shannon 指数的比较显示没有统计学上的显着差异 (p > 0.05)。 5.干预前后以及三组间肠道微生物定性分析均无显着差异。 Anosim 测试结果也没有揭示定性差异（Anosim 测试 R = 0.021，p = 0.215）。 6. LEfSe 分析显示，干预后金匮仁气丸组中 Prevotella_7 丰度显着增加 (p < 0.05)。 7. 此外，中医证据评分、体重指数、TC 和 LDL 水平与 Tyzzerella_3 菌群的相对丰度呈正相关。相反，年龄、病程和2hPBG与Christensenellaceae_R_7菌群的相对丰度呈正相关，而TC和LDL水平与Christensenellaceae_R_7菌群的相对丰度呈负相关。金匮仁气丸联合西医治疗表现出优越性。与单纯西医治疗相比，DKD 患者在改善临床症状和降低 ACR 方面具有疗效。此外，这种联合疗法导致患者肠道菌群内 Prevotella_7 丰度增加，表明肠道微生物群可能增强碳水化合物代谢。另一方面，两歧双歧杆菌四方片菌片联合西医治疗，与单独西医治疗相比，在降低 DKD 患者 TC 水平方面显示出更强的功效。此外，这种联合疗法有效降低了 DKD 患者的 IL-2 水平，从而减轻了这些患者的炎症。版权所有 © 2024 张、岳、王和吴。

To investigate the effects of Bifidobacterium bifidum tetragonum tablets and Jin Gui Ren Qi Pill on intestinal flora and metabolism in patients with diabetic kidney disease.In the study conducted at Heping Hospital of Changzhi Medical College from March 2021 to December 2022, 30 cases of patients diagnosed with diabetic nephropathy were meticulously selected as study subjects. Employing a double-blind randomized table method, these patients were randomly allocated into three groups: the control group (n = 10), the Bifidobacterium bifidum tetragonum tablets group (n = 10), and the Jin Gui Ren Qi Pill group (n = 10). The control group received standard western medical treatments for diabetic nephropathy, including serum glucose, blood lipids, blood pressure management, and other conventional therapies. In addition to the standard treatments, the Bifidobacterium bifidum tetragonum tablets group received Bifidobacterium bifidum tetragonum tablets, while the Jin Gui Ren Qi Pill group received Jin Gui Ren Qi Pill. Before and after a 4-week treatment period, various baseline parameters were assessed, including fasting blood glucose, 2-h postprandial blood glucose, triglycerides, serum total cholesterol, serum low-density lipoprotein cholesterol, serum high-density lipoprotein cholesterol, random urine microalbumin/creatinine ratio (ACR), blood creatinine (SCr), and traditional Chinese medicine evidence scores. Stool specimens were collected from all three groups before and after treatment for 16S rDNA high-throughput sequencing, followed by comprehensive analyses including OUT clustering, Alpha diversity, Beta diversity, species composition analysis, LEfSe analysis, and KEGG function prediction. Spearman correlation analysis was employed to explore the relationship between intestinal flora and clinical indicators. Furthermore, fasting peripheral venous blood was collected from patients in the Bifidobacterium tetrapunctate tablets group and the control group before and after intervention to measure the optical density values of tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), and interleukin-6 (IL-6) using the Beijing Biolite ELISA kit. This study was conducted with the approval of the Ethics Committee of Changzhi Medical College.1. The 2hPBG, total cholesterol and LDL levels were observed among patients with diabetic kidney disease (DKD) across all groups: the Jin Gui Ren Qi Pill group, the Bifidobacterium bifidum tetragonum tablets group, and the control group (p < 0.05). 2. The Jin Gui Ren Qi Pill demonstrated superior efficacy in alleviating TCM symptoms and reducing the ACR compared to both the Bifidobacterium bifidum tetragonum tablets group and the control group. Conversely, Bifidobacterium bifidum tetragonum tablets exhibited a more pronounced reduction in TC levels compared to both the Jin Gui Ren Qi Pill and control groups. Notably, Bifidobacterium bifidum tetragonum tablets effectively decreased (IL-2) levels in patients with DKD. 3. Bifidobacterium bifidum tetragonum tablets also demonstrated efficacy in reducing IL-2 levels in DKD patients. 4. Analysis of intestinal microorganism abundance and diversity before and after the intervention, as well as among the three groups, revealed no significant alterations. Similarly, comparisons of ACE, Chao, Simpson, and Shannon indices showed no statistically significant differences (p > 0.05). 5. Qualitative analysis of intestinal microorganisms before and after intervention, as well as among the three groups, indicated no significant differences. Anosim test results also did not reveal qualitative distinctions (Anosim test R = 0.021, p = 0.215). 6. LEfSe analysis unveiled a noteworthy increase in Prevotella_7 abundance within the Jin Gui Ren Qi Pill group post-intervention (p < 0.05). 7. Furthermore, Chinese medicine evidence scores, body mass index, TC, and LDL levels correlated positively with the relative abundance of Tyzzerella_3 bacterial flora. Conversely, age, disease duration, and 2hPBG correlated positively with the relative abundance of Christensenellaceae_R_7 flora, while TC and LDL levels displayed a negative correlation with the relative abundance of Christensenellaceae_R_7 flora.The combination of Jin Gui Ren Qi Pill with western medical treatment exhibited superior efficacy in ameliorating clinical symptoms and reducing the ACR in patients with DKD compared to western medical treatment alone. Furthermore, this combination therapy led to an increase in the abundance of Prevotella_7 within the intestinal flora of patients, suggesting a potential enhancement in carbohydrate metabolism by the intestinal microbiota. On the other hand, Bifidobacterium bifidum tetragonum tablets bacterial tablets combined with western medical treatment demonstrated enhanced efficacy in reducing TC levels in DKD patients compared to western medical treatment alone. Additionally, this combination therapy effectively reduced the levels of IL-2 in DKD patients, thus mitigating inflammation in these individuals.Copyright © 2024 Zhang, Yue, Wang and Wu.